Radiation Therapy And Docetaxel With Either Fluorouracil Or Cisplatin As First-Line Therapy In Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

Study Overview

Radiation Therapy and Docetaxel With Either Fluorouracil or Cisplatin as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy, docetaxel, and fluorouracil are more effective than radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic cancer. PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and fluorouracil to see how well they work as first-line therapy compared to radiation therapy, docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

OBJECTIVES: Primary * Compare the 6-month progression-free survival rate in patients with unresectable metastatic adenocarcinoma of the pancreas treated with radiotherapy and docetaxel in combination with either fluorouracil or cisplatin as first-line therapy. Secondary * Compare the toxicity of these regimens in these patients. * Compare the objective response rate in patients treated with these regimens. * Compare overall survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo radiotherapy to the celiac area once daily 5 days a week for 6 weeks. Patients also receive docetaxel IV weekly and fluorouracil IV daily for 6 weeks. * Arm II: Patients undergo radiotherapy and receive docetaxel as in arm I. Patients also receive cisplatin IV weekly for 6 weeks. In both arms, patients experiencing disease progression after completion of chemoradiotherapy may receive additional courses of chemotherapy. PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 3 years.

Pancreatic Cancer

DRUG: cisplatin
DRUG: docetaxel
DRUG: fluorouracil
RADIATION: radiation therapy

CDR0000430095
FRE-FNCLCC-ACCORD-09/0201
EU-20511

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2005-06-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-02-15
First Submitted that Met QC Criteria 2005-06-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-02-17
First Posted (ACTUAL) 2005-06-03	Results First Posted N/A	Last Verified 2021-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm 1	DRUG: docetaxel DRUG: fluorouracil RADIATION: radiation therapy
EXPERIMENTAL: Arm 2	DRUG: cisplatin DRUG: docetaxel RADIATION: radiation therapy

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm 1

DRUG: docetaxel

DRUG: fluorouracil

RADIATION: radiation therapy

EXPERIMENTAL: Arm 2

DRUG: cisplatin

DRUG: docetaxel

RADIATION: radiation therapy

Primary Outcome Measures	Measure Description	Time Frame
Progression-free survival rate at 6 months

Secondary Outcome Measures	Measure Description	Time Frame
Toxicity
Objective response rate
Overall survival

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed adenocarcinoma of the pancreas

No other pancreatic tumor type, including either of the following:

Neuroendocrine tumor
Ampulla of Vater carcinoma
Metastatic disease
Measurable or evaluable disease
Unresectable disease, defined as either of the following:

Failed prior attempt of surgical resection by laparotomy
Surgical resection contraindicated by radiographic criteria (e.g., arterial vascular invasion)
No cerebral metastases

18 to 75

Karnofsky 70-100%

Not specified

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Bilirubin < 1.5 times upper limit of normal
No hepatic disturbance

Creatinine < 120 mmol/L

No untreated cardiac or coronary insufficiency
No uncontrolled symptomatic arrhythmia
No uncontrolled angina

No uncontrolled respiratory insufficiency

Not pregnant or nursing
Fertile patients must use effective contraception
No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix
No peripheral neuropathy ≥ grade 2
No ongoing active infection
No other serious uncontrolled medical disorder that would preclude study treatment

Not specified

No prior chemotherapy

Not specified

No prior radiotherapy to the celiac or pancreatic area

See Disease Characteristics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Michel Ducreux, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Oberic L, Viret F, Baey C, Ychou M, Bennouna J, Adenis A, Peiffert D, Mornex F, Pignon JP, Celier P, Berille J, Ducreux M. Docetaxel- and 5-FU-concurrent radiotherapy in patients presenting unresectable locally advanced pancreatic cancer: a FNCLCC-ACCORD/0201 randomized phase II trial's pre-planned analysis and case report of a 5.5-year disease-free survival. Radiat Oncol. 2011 Sep 26;6:124. doi: 10.1186/1748-717X-6-124.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record